Determination of Dose of Antiangiogenic Multitargeted DOVITINIB (TKI258) Plus Paclitaxel in Patie… (NCT01548924) | Clinical Trial Compass
TerminatedPhase 1
Determination of Dose of Antiangiogenic Multitargeted DOVITINIB (TKI258) Plus Paclitaxel in Patients With Solid Tumors
Stopped: Drug toxicity
Spain13 participantsStarted 2012-04
Plain-language summary
The investigators plan to study the determination of the dose and the combination of antiangiogenic effect of dovitinib and cytotoxic activity of weekly paclitaxel in different types of malignant tumors.
Who can participate
Age range18 Years – 76 Years
SexALL
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Inclusion Criteria:
* Have signed the informed consent of study and be willing to undergo an image-guided biopsy and blood sampling for FC.
* Men or women over 18 years.
* Patients with solid tumors locally advanced or metastatic confirmed by histological methods or cytological, not susceptible of cure, who received the standard treatment available. Participation of patients with more active malignancy.
* measurable or nonmeasurable disease as version 1.1. of RECIST
* Class 0 to 2 of the ECOG
* Have at least four weeks elapsed since the last normal or experimental antitumor treatment (six weeks for BCNU, CCNU or mitomycin C)
* Have recovered of any toxicity (except alopecia) to grade 0 or 1 according to common terminology criteria for adverse events from the National Cancer Institute (NCI CTCAE, version 4.0).
* Life expectancy of three months.
* Participation of patients with more active malignancy.
* The baseline analytical data required are:
* Absolute neutrophil count (ANC) ≥ 1.500/mm3 \[1.5 x 109/l\]
* Platelets ≥ 75.000/mm3 \[75 x 109/l\]
* Hemoglobin ≥ 8.0 g / dL \[80 g/l\]
* Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
* Bilirubin ≤ 1.5 x ULN.
* AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN (with or without liver metastases)
* Concentration of electrolytes:
* Potassium \< LIN (3.0 mmol/l) or \> ULN (5.5 mmol/l)
* Sodium \< LIN (130 mmol/l) or \> ULN (150 mmol/l)
* Women of childbearing potential must have a negative pregnancy test within 7 days prio…
What they're measuring
1
Maximum tolerated dose (MTD)
Timeframe: After priming phase (7 days)
Trial details
NCT IDNCT01548924
SponsorCentro Nacional de Investigaciones Oncologicas CARLOS III